Device for prevention of involuntary urination

Abstract

The device comprises a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra. The body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end, and is made from a compressive and elastically deformable material. The body comprises at least one part protruding from the outer surface of the body and providing at least one pressure area for contact with the neck of the bladder and optionally the urethra.

What is claimed is:  
     
       1. A vaginal device for prevention of involuntary urination in a female having a vagina and a bladder, comprising a body arranged in an inserted position in the vagina, said body having a substantially elongated shape with a longitudinal axis extending, in an intended direction of insertion, from a proximal to a distal end, said body being made from a compressive and elastically deformable material and further including at least one part protruding circumferentially from an outer surface of the body, substantially perpendicular to the longitudinal axis and approximately midway therealong, providing at least one pressure area for compressive action on and support of the neck of the bladder through a vaginal wall, said pressure area preventing involuntary urination while allowing the female to urinate voluntarily with said device in said inserted position, said body also being provided with at least one string extending from the distal end. 
     
     
       2. A device according to  claim 1 , characterized in that the device is substantially symmetric with respect to the longitudinal axis of the body, preferably axisymmetric. 
     
     
       3. The device according to  claim 2 , wherein the device is substantially axisymmetric with respect to the longitudinal axis of the body. 
     
     
       4. The device according to  claim 1 , wherein the body comprises at least two protruding parts having an adjacent low part shaped as a narrowed waist between them. 
     
     
       5. The device according to  claim 4 , wherein the body comprises three protruding parts substantially perpendicular to said longitudinal axis and substantially parallel with one another, a first protruding part nearest said distal end having a first circumference, a second protruding part having a second circumference smaller than said first circumference and separated from said first protruding part by a first adjacent low part, and a third protruding part having a third circumference smaller than said second circumference, said third protruding part separated from said second protruding part by a second adjacent low part. 
     
     
       6. The device as set forth in  claim 5 , wherein said first and second adjacent low parts each have a width of at least 3 mm. 
     
     
       7. The device as set forth in  claim 5 , wherein a distance between a peak of a protruding part and a bottom of an adjacent low part is approximately 5 mm. 
     
     
       8. The device as set forth in  claim 4 , wherein said adjacent low part has a width of at least 3 mm. 
     
     
       9. The device according to  claim 1 , wherein the body is substantially conical or frusto-conical in shape. 
     
     
       10. A device according to  claim 9 , characterized in that said proximal end corresponds to the base of the conical or frusto-conical body. 
     
     
       11. A device according to any of the preceding claims, characterized in that the body is formed in polyurethane or polyvinyl alcohol. 
     
     
       12. A device according to any of  claims 1  to  10 , characterized in that the body is formed in a hydrophobic material, preferably hydrophobic polyurethane. 
     
     
       13. The device according to  claim 12 , wherein the hydrophobic material is a polyurethane. 
     
     
       14. A device according to any of the preceding claims, characterized in that the body is formed in a porous material. 
     
     
       15. The device according to  claim 1 , wherein the body is arranged in the vagina for compressive action on and support of the urethra as well as the neck of the bladder. 
     
     
       16. The combination of an applicator and a vaginal device for prevention of involuntary urination in a female having a vagina and a bladder, comprising a body arranged in an inserted position in the vagina, said body having a substantially elongated shape with a longitudinal axis extending, in an intended direction of insertion, from a proximal to a distal end, said body being made from a hydrophobic, compressive and elastically deformable material and being substantially conical or frusto-conical in shape with a base corresponding to said proximal end, said body further including at least two parts protruding from an outer surface of the body, separated by an adjacent low part and extending substantially parallel to the longitudinal axis of the body to provide at least one pressure area for compressive action on and support of the neck of the bladder through a vaginal wall, said body further having at least one string extending from the distal end and said applicator including an elongated member for abutment with at least said distal end of the body of the device during insertion. 
     
     
       17. The combination according to  claim 16 , characterized in that the body is provided with an indentation in said distal end; and that the applicator comprises one substantially rod-shaped end portion for abutment with said indentation. 
     
     
       18. The combination according to  claim 17 , wherein the applicator has marks for indicating the introduction depth of the applicator at its distal end. 
     
     
       19. The combination according to  claim 16 , wherein the elongated member of the applicator comprises an internal substantially tubular part which fits into an external substantially tubular part. 
     
     
       20. The combination according to  claim 19 , wherein the external substantially tubular part is open at both ends and defines a cavity for accommodating said device in a compressed and elastically deformed state. 
     
     
       21. The combination according to  claim 19 , wherein the internal substantially tubular part accommodates the device in a compressed and elastically deformed state. 
     
     
       22. A method of manufacturing a device according to  claim 1 , comprising the steps of mixing the components of the material, injecting the material into a mold, optionally accelerating hardening of the material by heating the mold, and removing the body from the mold. 
     
     
       23. A method according to  claim 22 , in which at least one string is fastened to the body at any stage of the process. 
     
     
       24. A method according to  claim 23 , in which the string is fastened to at least one portion of the mould prior to the injection of the material into said mould. 
     
     
       25. The combination as set forth in  claim 21 , wherein the applicator reduces a circumference of the device at time of insertion by at least 50%. 
     
     
       26. A vaginal device for prevention of involuntary urination in a female having a vagina and a bladder, comprising a body arranged in an inserted position in the vagina, said body having a substantially elongated shape with a longitudinal axis extending, in an intended direction of insertion, from a proximal to a distal end, said body being made from a compressive and elastically deformable material and including at least two protruding parts extending substantially parallel to the longitudinal axis of the body and separated by an adjacent low part, said protruding parts providing at least one pressure area for compressive action against the neck of the bladder through the vaginal wall and said low part between said two protruding parts making a cradle which fits the neck of the bladder for support, said body preventing involuntary urination while allowing the female to urinate voluntarily with said device in said inserted position, said body further being provided with at least one string extending from the distal end. 
     
     
       27. The device according to  claim 26 , wherein the device is substantially symmetric with respect to the longitudinal axis of the body. 
     
     
       28. The device according to  claim 26 , wherein the body comprises at least three protruding parts extending substantially parallel to the longitudinal axis of the body, with each protruding part separated from the others by an adjacent low part. 
     
     
       29. The device according to  claim 28 , wherein the protruding parts are spaced approximately equidistantly from one another around the circumference of the body. 
     
     
       30. The device according to  claim 26 , wherein the body is substantially conical or frusto-conical in shape. 
     
     
       31. The device according to  claim 30 , wherein the body comprises at least three protruding parts extending substantially parallel to the longitudinal axis of the body, with each protruding part separated from the others by an adjacent low part. 
     
     
       32. The device according to  claim 31 , wherein the protruding parts are spaced approximately equidistantly from one another around the circumference of the body. 
     
     
       33. The device as set forth in  claim 31 , wherein said adjacent low parts each have a width of at least 3 mm. 
     
     
       34. The device as set forth in  claim 31 , wherein a distance between a peak of a protruding part and a bottom of an adjacent low part is approximately 5 mm. 
     
     
       35. The device according to  claim 30 , wherein said proximal end corresponds to a base of the conical or frusto-conical body.